Data Collection Protocol for Patients With Von Hippel Lindau Disease

Von Hippel Lindau Disease Clinical Trial

Official title:

Data Collection Protocol for Patients With Von Hippel Lindau Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05955014
• Other study ID #: 2022-0665
• Secondary ID: NCI-2023-05216
• Status: Recruiting
• Start date: August 24, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: August 2023
• Source: M.D. Anderson Cancer Center
• Contact: Eric Jonasch, MD
• Phone: (713) 563-7232
• Email: ejonasch[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To collect information from patients with vHL disease. Information collected will include data on the status of the disease, any surgeries or therapies patients have received for vHL disease, and quality of life.

Description:

Primary Objectives:

• Obtain prospective and retrospective data on lesion development, surgical history and systemic therapy use in patients with vHL disease

• Assess genotype-phenotype correlation between VHL mutation type and patterns of lesion development

• Assess genotype-phenotype correlation for response to belzutifan in an organ-specific manner

Secondary Objectives:

--Obtain quality of life data in patients with vHL disease

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Presence of genetic confirmation or clinical criteria consistent with vHL disease.

• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Patients with psychiatric illness/social situations that would limit compliance with study requirements.

Related Conditions & MeSH terms

• Von Hippel Lindau Disease
• Von Hippel-Lindau Disease

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)		through study completion; an average of 1 year

External Links

•   M D Anderson Cancer Center